SURESOUND SOUND12

MAUDE Adverse Event Report

MAUDE data represents reports of adverse events involving medical devices. This maude entry was filed from a 05,06,07 report with the FDA on 2014-03-20 for SURESOUND SOUND12 manufactured by Hologic.

Event Text Entries

[4336292] Note: this report pertains to the first of two hologic devices used in the same procedure. See associated medwatch, manufacturer's report number 1222780-2014-00046. It was reported that during a novasure endometrial ablation on (b)(6) 2014, a physician received two unsuccessful cavity integrity assessment (cia) tests. The physician removed the disposable device and performed a hysteroscopy. There was no perforation found. The procedure was aborted and the patient was discharged home. "approximately 24 hours post attempted ablation, the patient reported chest pain. Upon observation on or around (b)(6) 2014, the patient is found with air under diaphragm. " possible perforation suspected. It was reported on (b)(6) 2014, the patient was "just observed for 24 hours" and "the patient is doing fine. " a hysteroscopy and dilatation, (not hologic devices) were performed prior to the attempted ablation. It is not known when the suspected perforation occurred or what instrument may have been the cause.
Patient Sequence No: 1, Text Type: D, B5


[11606979] Lot number of the suresound not provided by the complainant, therefore the expiration date is not known. The suresound is not being returned therefore, a failure analysis of the complaint device cannot be completed. Lot number of the suresound not provided by the complainant, therefore the manufacture date is not known. Device history record (dhr) review could not be conducted for the suresound as a lot number was not provided by the complainant. (b)(4).
Patient Sequence No: 1, Text Type: N, H10


MAUDE Entry Details

Report Number1222780-2014-00053
MDR Report Key3698627
Report Source05,06,07
Date Received2014-03-20
Date of Report2014-02-18
Date of Event2014-02-13
Date Facility Aware2014-02-13
Date Mfgr Received2014-02-18
Date Added to Maude2014-03-26
Event Key0
Report Source CodeManufacturer report
Manufacturer LinkY
Number of Patients in Event0
Adverse Event Flag3
Product Problem Flag3
Reprocessed and Reused Flag3
Health Professional3
Initial Report to FDA3
Report to FDA0
Event Location0
Manufacturer ContactCRAIG CALLAHAN, MANAGER
Manufacturer Street250 CAMPUS DRIVE
Manufacturer CityMARLBOROUGH MA 01752
Manufacturer CountryUS
Manufacturer Postal01752
Manufacturer Phone5082638859
Single Use3
Previous Use Code3
Event Type3
Type of Report3

Device Details

Brand NameSURESOUND
Product CodeHHM
Date Received2014-03-20
Model NumberNA
Catalog NumberSOUND12
Lot NumberUNK
ID NumberNA
OperatorHEALTH PROFESSIONAL
Device AvailabilityN
Device AgeNA
Device Eval'ed by MfgrR
Device Sequence No1
Device Event Key0
ManufacturerHOLOGIC
Manufacturer AddressMARLBOROUGH MA US


Patients

Patient NumberTreatmentOutcomeDate
101. Other 2014-03-20

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